(185 days)
Indicated for the injection of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with, dental procedures.
The CCS computer controlled syringe is a programmable electronic device that allows the injection of local anesthetics commercially available and packaged in cartridge form. The device consists of a programmable control unit, and a handpiece with switches that actuate the function of the device as programmed. Single use, replacement cartridge holders are available to facilitate universal injection technique.
This looks like a submission record to the FDA for a 510(k) premarket notification for a medical device. Based on the provided text, there is no information about specific acceptance criteria, a study proving device performance against those criteria, or the details typically associated with clinical performance studies (sample sizes, ground truth establishment, expert qualifications, etc.).
The document {0} states "Performance data is presented in the 510(k) submission," but this specific summary does not contain that data or the acceptance criteria. The subsequent pages {1}, {2}, and {3} are an FDA response letter confirming substantial equivalence to a predicate device and the "Indications For Use" statement.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets those criteria, as these details are not present in the provided text.
§ 872.6770 Cartridge syringe.
(a)
Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.